lasmiditan succinate - Profile

What are the generic drug sources for lasmiditan succinate and what is the scope of patent protection?

Lasmiditan succinate is the generic ingredient in one branded drug marketed by Eli Lilly And Co and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lasmiditan succinate has one hundred and ninety-one patent family members in forty-eight countries.

Summary for lasmiditan succinate

International Patents:	191
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lasmiditan succinate

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lasmiditan succinate

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for LASMIDITAN SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REYVOW	Tablets	lasmiditan succinate	50 mg and 100 mg	211280	1	2024-01-31

US Patents and Regulatory Information for lasmiditan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No			Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No			Y	Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020		RX	Yes	No			Y
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020		RX	Yes	Yes			Y	Y

Expired US Patents for lasmiditan succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-003	Dec 18, 2020
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-001	Jan 31, 2020
Eli Lilly And Co	REYVOW	lasmiditan succinate	TABLET;ORAL	211280-002	Jan 31, 2020

International Patents for lasmiditan succinate

Country	Patent Number	Title	Estimated Expiration
Australia	2017373784
Brazil	112019010934
Canada	3043772
Chile	2019001426
China	110291079

Supplementary Protection Certificates for lasmiditan succinate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2413933	202240053	Slovenia		PRODUCT NAME: LASMIDITAN; NATIONAL AUTHORISATION NUMBER: EU/1/21/1587; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2413933	2023C/503	Belgium		PRODUCT NAME: LASMIDITAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1587 20220819
2413933	PA2023502,C2413933	Lithuania		PRODUCT NAME: LASMIDITANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1587 20220817
2413933	1/2023	Austria		PRODUCT NAME: LASMIDITAN; REGISTRATION NO/DATE: EU/1/21/1587 (MITTEILUNG) 20220819
2413933	PA2023502	Lithuania		PRODUCT NAME: LASMIDITANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/21/1587 20220817

Lasmiditan Succinate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Lasmiditan succinate, marketed under the brand name Reyvow, is a prescription medication approved by the US Food and Drug Administration (FDA) in October 2019 for acute treatment of migraines in adults. As a selective 5-HT1F receptor agonist, it represents an innovative approach in migraine therapy, offering an alternative to triptans, especially for patients with cardiovascular risk factors. This analysis evaluates the investment landscape, market dynamics, and financial trajectory of lasmiditan succinate, considering current clinical, regulatory, and commercial factors influencing its growth prospects.

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What Is the Current Market Environment for Lasmiditan Succinate?

Aspect	Description
Market Size	The global migraine drug market was valued at ~$3.2 billion in 2022, projected to grow at 4.2% CAGR, reaching ~$4.2 billion by 2030 (source: Grand View Research).
Target Population	Approx. 1 billion individuals globally suffer from migraines; approximately 20-30% have debilitating episodic or chronic migraines (source: WHO).
Competitors	Triptans (~$2.8 billion in sales globally), gepants (ubrogepant, rimegepant), ditans (lasimiditan), NSAIDs, and CGRP monoclonal antibodies (e.g., erenumab).

Investment Scenario for Lasmiditan Succinate

1. Market Penetration and Adoption Potential

• Target Patient Demographics: Patients contraindicated or intolerant to triptans, including those with cardiovascular risks.

• Physician Adoption: Limited early adoption owing to safety concerns, side effect profiles, and existing competition from CGRP antagonists.

• Pricing Strategy: List price approximately $50-$60 per dose (FDA label suggests high cost due to novel mechanism), influencing payer coverage and reimbursement.

Adoption Barriers	Opportunities
Safety profile concerns	Favorable safety data for cardiovascular safety
Competition from CGRP drugs	Synergistic or alternative use cases
Insurance coverage	Early access programs, stepped therapy approaches

2. Regulatory and Clinical Development Path

• FDA Approval: Achieved as a new chemical entity (NCE), fast-tracked due to unmet need.
• Additional Indications: Exploring preventive use, chronic migraine, or off-label applications could expand market potential.
• Post-Approval Trials: Ongoing studies for migraine prevention; positive results could heighten interest.

3. Patent and Exclusivity Timeline

Patent Type	Expiry Year	Notes
Compound Patent	~2035	Expected, based on filing timelines (USPTO filings from 2014)
Use Patent	Additional 5-10 years	For specific indications
Data Exclusivity	5 years post-approval	FDA data protection until 2024

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Market Dynamics Affecting Lasmiditan Succinate

Factor	Impact	Source/Notes
Competitive Landscape	Challengers like Rimegepant (Nurtec), Ubrogepant (Ubrelvy)	Marketed since 2019-2020, targeting similar patient base
Reimbursement Trends	Insurance coverage expansion	2022-2023 coverage by Medicare, private insurers noted for CGRP inhibitors, potentially applicable for lasmiditan
Innovation in Migraine Management	Emphasis on personalized medicine	Lasmiditan’s unique 5-HT1F mechanism positions it favorably for niche markets

Key Market Trends

• Shift Towards Non-vasoconstrictive Agents: Lasmiditan’s lack of vasoconstriction aligns with safety-focused prescribing.
• Increasing Use in Chronic and Refractory Migraine: Potential for expansion into these subpopulations.
• Digital Health Integration: Telemedicine adoption for migraine management could streamline access and monitoring.

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Financial Trajectory Analysis

1. Sales Projections

Year	Estimated Sales (USD millions)	Assumptions
2023	$40-$60	Initial launch phase, modest market penetration
2025	$150-$250	Increased clinician adoption, expanding indications
2030	$500+	Shift towards broader use, potential line extensions

(Source: Analyst consensus, company disclosures)

2. Revenue Drivers

• Pricing and Reimbursement: List price influences cash flow; negotiations with payers critical.
• Physician Adoption Rate: Faster adoption for high-risk patients accelerates revenue.
• Market Expansion: Geographic expansion outside the US and additional indications could amplify sales.

3. Cost Structure and Profitability

Expense Category	Estimated % of Revenue	Notes
R&D	15-20%	Ongoing studies for additional indications
Marketing & Sales	25-30%	Key for market penetration
Manufacturing	10%	Economies of scale expected over time

Comparative Analysis with Peer Drugs

Drug	Market Launch	Indications	CAGR	Approximate US Sales (2022)	Patent Status	Mode of Action
Rimegepant (Nurtec)	2020	Acute, prevention	18%	$726M	Patent until ~2033	CGRP antagonist
Ubrogepant (Ubrelvy)	2019	Acute migraine	N/A	$432M	Patent until ~2032	CGRP antagonist
Lasimiditan (Reyvow)	2019	Acute migraine	N/A	~$150M	Key patents until ~2035	5-HT1F agonist

(Source: IQVIA, company reports)

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Deep-Dive: Investment Risks and Opportunities

Risks	Mitigation Strategies	Opportunities
Competition from CGRP inhibitors	Position as alternative, especially for contraindications	Patient segment underserved by existing therapies
Market penetration delay	Educational campaigns, formulary negotiations	Early adoption by specialized clinics and neurologists
Safety concerns	Robust post-market surveillance	Long-term data supporting safety profile

Regulatory and Legal Factors Influencing Financial Trajectory

Factors	Impact	Notes
Patent Litigation	Potential delays or extensions	Ongoing patent challenges, patent strength critical
Regulatory Changes	Reimbursement policies	CMS and private insurer policies shifting toward value-based care
International Approvals	Market expansion	EMA, PMDA approvals pending or under review

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Concluding Market Outlook and Investment Recommendations

• Growth Potential: High for niche segment of migraine patients contraindicated for triptans. Sales could reach $500+ million by 2030 in the U.S. alone.
• Key Drivers: Efficacy, safety profile, physician acceptance, payer reimbursement.
• Risks: Competitive landscape intensifies, pricing pressures, slow adoption.
• Strategic Focus: Enhance clinical data, expand indications, collaborate with payers, and strengthen patent protection.

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Key Takeaways

• Market Opportunity: Lasmiditan succinate's unique mechanism positions it within a growing migraine market, especially appealing for patients unable to use triptans.
• Investment Viability: Promising based on unmet needs, innovative profile, and projected sales growth, contingent on clinical and commercial execution.
• Competitive Edge: Advantages stem from safety for cardiovascular risk patients and potential expansion into preventive therapy.
• Risks & Challenges: Market penetration and reimbursement hurdles, patent litigation, and intensified competition from established CGRP therapies.
• Future Outlook: Potential for sustained growth extending beyond initial indications, with line extensions and international approvals bolstering long-term revenue streams.

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FAQs

1. How does lasmiditan differentiate from other migraine drugs?
Lasmiditan acts as a selective 5-HT1F receptor agonist, offering a non-vasoconstrictive mechanism, making it safer for patients with cardiovascular risks—an advantage over triptans and some gepants.

2. What are the primary challenges in commercializing lasmiditan?
Challenges include establishing clinician confidence, payer coverage negotiations, competing therapies, and differentiating the drug amid rapidly evolving migraine pharmacotherapy.

3. What is the patent outlook for lasmiditan?
Patent protection extends into the mid-2030s, with potential for extensions via method-of-use patents, supporting a period of market exclusivity.

4. How does lasmiditan’s sales forecast compare with existing migraine therapies?
Sales are expected to reach several hundred million dollars annually by 2030, but compete with established drugs like ubrogepant and rimegepant, which already generate high revenues.

5. Are there any ongoing trials that could further influence the drug’s market potential?
Yes, ongoing Phase 3 trials exploring preventive applications and chronic migraine are underway, potentially broadening the drug’s market applicability.

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References

[1] Grand View Research. Migraine Drugs Market Size & Analysis (2022).
[2] WHO. Migraine Fact Sheet (2021).
[3] IQVIA. Global Migraine Drug Sales Data (2022).
[4] US FDA. Reyvow (Lasmiditan) Approval Announcement (2019).
[5] Company filings and investor presentations (2019–2023).